Surgical stapler

ABSTRACT

A surgical stapler, a cartridge for a surgical stapler, a cutting mechanism for a surgical stapler, and a method of applying surgical staples in a patient are disclosed herein. The stapler may have an anvil movably coupled to a support jaw between a clamped configuration and a closed configuration. The cartridge may be configured to fit within an envelope diameter and to removably house a plurality of B-form staples, at least one of the plurality of B-form staples having a base length and a leg length, the leg length at least 53% of the envelope diameter. The cartridge may have slots shaped to house at least a second one of the plurality of staples at an angle oblique to the first one of the plurality of staples.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.15/916,503, filed Mar. 9, 2018 and entitled “SURGICAL STAPLER,” which isa continuation of U.S. patent application Ser. No. 15/827,250, filledNov. 30, 2017 and entitled “SURGICAL STAPLER,” which is a continuationof U.S. patent application Ser. No. 15/148,744, filed May 6, 2016, andentitled “SURGICAL STAPLER,” which claims priority to U.S. ProvisionalApplication No. 62/159,191, filed May 8, 2015 and entitled “SURGICALSTAPLER,” the entire disclosure of which is hereby incorporated byreference for all proper purposes.

BACKGROUND

A surgical stapler is a medical device which is used to place surgicalstaples in a patient to close wounds ranging from bowel resections toskin incisions and others.

The staples to be applied to the tissue must be selected based on thethickness of the tissue to be stapled. Generally, larger staples requirethe use of surgical staplers that are also larger. For example, one 5 mmstapler sold under the trademark JustRight™, has a nominal shaftdiameter of about 5 mm, and is currently indicated for applying stapleshaving a nominal leg length of about 2 mm. Put another way, the 5 mmJustRight™ Surgical Stapler is indicated for use in procedures in whichthe tissue can be clamped between the stapler jaws to about 1 mm orless. JustRight™ is a trademark belonging to the assignee of thisapplication.

Some currently-available staplers, such as a stapler sold under thetrademarks Cardica™ MicroCutter Xchange^(R) 30, do not use staplesdefined by a leg length; nonetheless, these staplers are similarlylimited in that the staplers cannot staple tissue if the tissue cannotbe clamped to a certain thickness. Should the surgeon need to stapletissue clamped to, for example, 2 mm, the surgeon would be required touse a stapler that is around 12 mm in diameter.

Some manufacturers have attempted to provide a relatively small staplerthat may staple relatively thick tissue, such as the Cardica™ staplerdescribed above. However, these staplers use what are known as D-shapedstaples, as illustrated in FIGS. 35A-35B, instead of the more commonB-form staples, which are illustrated in FIGS. 35C-35D. The D-shapedstaples have relatively thick legs, with one of the legs not having apiercing feature, and have not been subject to extensive field use. Itis believed by the Inventors that, for a given tissue thickness, theD-shaped staples introduce more trauma to the patient than do the B-formstapes.

While the use of a larger stapler for placing larger staples is oftenacceptable, in certain medical procedures, such as in proceduresperformed on small or weak patients, such as small children or thosewith physical or disease trauma, it may be desirable to use a relativelysmall shaft surgical device to staple tissue that is relatively thick,using a B-form staple.

Moreover, it is known that, if a surgeon clamps onto too much tissue fora given staple leg length or indicated use, currently-available staplerscould still fire the staples and cut the tissue improperly. That is, thecurrently-available staplers could fire the staples, and thereafter cutthe tissue, leaving the site open. It may therefore be desirable toprovide a stapler that does not leave the site open or unsealed if thestaples are not properly placed.

It may also be desirable to provide a surgeon the ability to create awider cuff (that is, a larger tissue margin between the staples andtransection line) for a given clamped tissue thickness than is possibleusing the currently-available surgical devices.

There therefore remains a need for a relatively small surgical staplercapable of stapling relatively thick tissue using B-form staples and/orproviding a relatively wider cuff, with less impact to the patient, aswell as other new and innovative features.

FIELD

The present disclosure relates generally to surgical instruments, andmore specifically to endosurgical staplers and/or methods of placingsurgical staples in a patient.

SUMMARY

In some examples, a cartridge for a surgical stapler is provided. Theexemplary cartridge has an elongated body configured to fit within anenvelope diameter and to removably house a plurality of B-form staples.At least one of the plurality of B-form staples has a base length and aleg length, the leg length at least 53% of the envelope diameter. Theexemplary cartridge also has a tissue clamping interface, a first slotshaped to receive a translating cutting mechanism, and a second slotshaped to house at least a first one of the plurality of staples. Theexemplary cartridge also has a third slot shaped to house at least asecond one of the plurality of staples at an angle oblique to the firstone of the plurality of staples.

In some examples, a surgical stapler is provided. The exemplary surgicalstapler, has an anvil movably coupled to a support jaw between a clampedconfiguration, and a closed configuration wherein a tissue clampinginterface in the anvil abuts a tissue clamping interface in thecartridge. The exemplary support jaw has a cartridge having an elongatedbody configured to removably house a plurality of B-form staples. Atleast one of the plurality of B-form staples has a base length and a leglength. The exemplary cartridge further comprises a first slot shaped toreceive a translating cutting mechanism, a second slot shaped to houseat least a first one of the plurality of staples, and a third slotshaped to house at least a second one of the plurality of staples at anangle oblique to the first one of the plurality of staples. The anviland the support jaw comprising the cartridge are shaped to fit within anenvelope diameter when in the closed configuration. The leg length ofthe at least one of the plurality of B-form staples is at least 53% ofthe envelope diameter in some examples.

In some examples, a method of placing a surgical staple in a patient isprovided. The exemplary method includes providing a surgical stapler ina closed configuration, the stapler comprising an anvil movably coupledto a support jaw between a clamped configuration and a closedconfiguration wherein a tissue clamping interface in the anvil abuts atissue clamping interface in the cartridge. The exemplary support jawcomprises a cartridge configured to removably house a plurality ofB-form staples, at least one of the plurality of B-form staples having abase length and a leg length. The exemplary cartridge has a first slotshaped to receive a translating cutting mechanism, a second slot shapedto house at least a first one of the plurality of staples, and a thirdslot shaped to house at least a second one of the plurality of staplesat an angle oblique to the first one of the plurality of staples. Theexemplary anvil and support jaw comprising the cartridge are shaped tofit within an envelope diameter when in the closed configuration. Theleg length of the at least one of the plurality of B-form staples is atleast 53% of the envelope diameter in some examples. The exemplarymethod also includes passing at least a portion of the stapler in theclosed configuration through an envelope diameter, and positioningtissue between the anvil and the support jaw. The exemplary method alsoincludes moving the anvil to the clamped configuration wherein the anviland the support jaw clamp the tissue between the anvil and the supportjaw. The exemplary method also includes causing the stapler to form theplurality of staples about the tissue.

In some examples, a surgical stapler is provided. The exemplary staplerhas a translating cutting mechanism having a first member having acutting portion, and a second member. The exemplary cutting mechanism ismovable between a collapsed configuration wherein the cutting mechanismis shaped to fit within the envelope diameter and an expandedconfiguration wherein the cutting mechanism does not fit within theenvelope diameter.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a perspective view of a surgical stapler coupled to anactuator;

FIG. 1B is a perspective view of the surgical stapler in FIG. 1A;

FIG. 2 is an exploded perspective view of the surgical stapler in FIG.1B;

FIG. 3 is a perspective view of a cartridge in the stapler in FIG. 1B;

FIG. 4 is a cross-section view of the cartridge in FIG. 3;

FIG. 5 is another cross-section view of the cartridge in FIG. 3;

FIG. 6 is a top view of the cartridge in FIG. 3;

FIG. 7 is a rotated top view of the cartridge in FIG. 3;

FIG. 8 is a perspective view of an anvil in the stapler in FIG. 1B;

FIG. 9 is a top view of the anvil in FIG. 8;

FIG. 10 is a bottom view of the anvil in FIG. 8;

FIG. 11 is a back view of the anvil in FIG. 8;

FIG. 12 is a perspective view of features in the anvil in FIG. 8;

FIG. 13 is a perspective view of features in the anvil in FIG. 8;

FIG. 14 is a cross-section view of a cartridge and anvil suitable forthe stapler in FIG. 1B;

FIG. 15 is a side view of features of the stapler in FIG. 1B;

FIG. 16 is a side view of features of the stapler in FIG. 1B;

FIG. 17 is a side view of features of the stapler in FIG. 1B;

FIG. 18 is a perspective view of a cutting mechanism in the stapler inFIG. 1B;

FIG. 19 is a perspective view of a cutting mechanism in the stapler inFIG. 1B;

FIG. 20A is a perspective view of the stapler in FIG. 1B;

FIG. 20B is a perspective view of the stapler in FIG. 1B;

FIG. 20C is a perspective view of the stapler in FIG. 1B;

FIG. 21 is a cross-section view of a clamp suitable for a stapler;

FIG. 22 is a perspective view of a staple pusher in the stapler in FIG.1B;

FIG. 23 is a first side view of the staple pusher in FIG. 22;

FIG. 24 is a second side view of the staple pusher in FIG. 22;

FIG. 25 is a perspective view of a lower anvil positioner in the staplerin FIG. 1B;

FIG. 26 is a perspective view of some components of the stapler in FIG.1B;

FIG. 27 is a side section view of some components of a stapler;

FIG. 28 is a perspective view of an integrated housing;

FIG. 29 is a cross-section view of a cartridge, staple pushers, andstaples;

FIG. 30 is a detailed view of the components in FIG. 29;

FIG. 31 is a cross-section view of a cartridge, staple pusher, andstaples;

FIG. 32 is a detailed view of the components in FIG. 31;

FIG. 33 is a cross-section view of a clamp and other components;

FIG. 34 is a cross-section perspective view of the clamp and othercomponents;

FIG. 35A is a side view of a D-shaped surgical staple prior toplacement;

FIG. 35B is a side view of the D-shaped staple in FIG. 35A in a placedconfiguration;

FIG. 35C is a side view of a B-form surgical staple prior to placement;

FIG. 35D is a side view of the B-form staple in FIG. 35C in a placedconfiguration; and

FIG. 36 is a flowchart of an exemplary method.

DETAILED DESCRIPTION

To meet the previously-described needs, and/or to provide other new anduseful features, a surgical stapler and method may be provided, and thisparagraph is intended to be a conceptual overview, so as to give thereader a better understanding of the detailed description that follows.In some examples, a surgical stapler having a relatively small size isprovided, and configured to place relatively large staples in a patient.This may be achieved by housing the staples at an oblique angle relativeto each other or a common datum, such as a longitudinal axis ortransection line. That is, instead of housing the staples parallel toeach other (and/or perpendicular to a flat tissue clamping interface),as is known in the art, the Inventors provide, in some examples, asystem in which the staples may be housed at a non-zero angle relativeto each other or a common datum, and directed to staple tissue clampedbetween a curved jaw/cartridge and a curved anvil. This configurationgives surgeons the previously-unavailable option of placing relativelylarge staples using a relatively small stapler. Put another way, thisconfiguration gives surgeons the previously-unavailable option ofstapling tissue using a device gap of more than 1.0 mm using a 5 mmstapler (nominal).

For the purpose of this document, the term “nominal” shall refer to arange of dimensions usual in the medical device and/or surgical staplerindustry at the time of invention or at the time of manufacture,whichever range is greater. For example, currently-available 5 mmstaplers (nominal) are known to vary across manufacturers from 5.0 to6.0 mm or 5.5+/−0.5mm. As another example, a cannula having a nominalinner diameter of 5.5 mm is known to have an actual inner diameter of atleast 5.59 mm as of the time of this writing, but may be greater as ofthe time of manufacture. A staple having a nominal leg length of 3.5 mmis known to have an actual leg length that varies by about +/−0.08 mm asof the time of this writing. Further, for the purpose of this document,all absolute terms, such as, for example, flat, parallel, perpendicular,round, etc., as well as all dimensions, shall be understood to includethe limitation “within reasonable manufacturing tolerances at the timeof the invention or at the time of manufacture, whichever are greater”.For the purpose of this document, the term “proximal” shall refer tothat portion or region of an instrument that is positioned closer to anintended user, such as a surgeon, and the term “distal” shall refer tothe end or region away from the user or surgeon.

Turning now to FIG. 1, it illustrates an exemplary endosurgical stapler100 passing through a cannula 400 in a manner known in the art andcoupled to a stapler actuator 800. The interior diameter of the cannula400 may be a nominal diameter of 5.0 mm or 5.5 mm, which may be up to6.0 mm with manufacturing tolerances or standards known in the art.Those skilled in the art will understand that the cannula 400 is placedin the patient to provide a port through which the surgeon may accessthe patient using the stapler 100. The stapler 100 may have an anvil 102that is configured to open or close relative to a support jaw 103. Thesupport jaw 103 may include a cartridge housing 104, which houses acartridge 106. In some embodiments, the housing 104 and cartridge 106may be a unitary feature referenced as a support jaw 103. The anvil 102and support jaw 103 may be coupled to or manipulated at a proximalregion by way of a shaft 116 that houses actuators and/or other controlmechanisms in a manner substantially as is known in the art.

To operate the anvil 102, an upper anvil positioner 110 and a loweranvil positioner 112 may be provided. The anvil positioners 110, 112 mayoperate to move the anvil 102 between an open position, a clampedposition, and a closed position in a coordinated manner, and as will bedescribed in further detail in subsequent sections of this document (seee.g. FIGS. 15-17).

Continuing with FIG. 1, a cutting mechanism 108 may be provided andmovable relative to the distal portion of the stapler 100, to cutstapled tissue held between the anvil 102 and the support jaw 103 in amanner to be described in further detail in subsequent sections.

Those skilled in the art will readily appreciate that the components ofthe stapler 100 in FIG. 1 can be manufactured from any number ofsuitable materials, and, more particularly, that the materials must beselected with a suitable strength so as to withstand the forces requiredto clamp and staple relatively large bands of tissue using relativelysmall features. For example, any number of engineering materials,including, but not limited to, high-strength surgical steels, ceramics,and/or polymers may be selected.

In some embodiments, the surgical stapler 100 may have a housing 104, aportion thereof having an envelope diameter of about 5.5 millimeters orconfigured to pass through a 5.5 mm cannula 400.

In some embodiments, a 5.5 mm nominal housing 104 may house or carry astaple having a 3.0 mm nominal leg length in a manner as previouslydescribed herein. In some embodiments, the staple has a 4.8 mm nominalleg length. In some embodiments, the staple has a 2.0 mm nominal leglength. In some embodiments, the staple has a 2.5 mm nominal leg length.

Turning now to FIG. 2, further details of the stapler 100 in FIG. 1 areillustrated in an exploded perspective view. As can be appreciated, thecartridge 106 may be configured to house one or more staple pushers 132such that, upon being actuated by one or more cams 128, 130, the staplepushers 132 may guide one or more staples (not illustrated in FIG. 2)out of the cartridge 106 and towards the anvil 102, whereby the staplesare formed about tissue clamped between the anvil 102 and the cartridge106/support jaw 103.

The cam(s) 128, 130 may be actuated in a manner that is known to thoseskilled in the art. That is, in some embodiments, a standard staplepusher and staple driving concept as is currently available is used. Insome embodiments, an extended cam and a reduced-size staple pusher maybe provided. An extended cam is a cam that is taller than ishistorically used in surgical staplers of comparable size. An extendedcam is therefore taller, to drive relatively large staple(s), such asstaples having a leg length of 3.0 mm or greater, but the staple pushersize is of a reduced size such that the leg length of the staple(s) isgreater than the pusher height, as is illustrated in FIG. 5. Thoseskilled in the art will recognize that, where the staple(s) 150 orstaple pusher(s) 132 are housed at an oblique angle Θ relative to eachother or to a transection line, the cam(s) 128, 130 are at a similarlydefined angle.

Returning to FIG. 2, the cutting mechanism 108 may have a first member118 and a second member 120 that are movable or expandable relative toeach other, and configured to move from a proximal region of the stapler100 towards a distal region of the stapler 100 to cut tissue clamped bythe stapler 100. The first member 118 of the cutting mechanism 108 maybe actuated, controlled, and/or retracted using a first actuator 122,and the second member 120 of the cutting mechanism 108 may be actuated,controlled, and/or retracted using a second actuator 124.

The upper anvil positioner 110 may be actuated using an upper anvilactuator 126, and the lower anvil positioner 112 may be actuated using alower anvil actuator (not illustrated). The lower anvil positioner 112may have one or more flanges 112 a, 112 b configured to engage multiplesurfaces of the anvil 102, to, in coordination with the upper anvilpositioner 110, open, clamp, or close the anvil 102.

A spring 113 may be provided so as to maintain the anvil 102 biasedtowards the closed position even if the surgeon rotates the stapler 100upside-down. That is, the spring 113 may prevent the anvil 102 fromopening prior to intentional actuation, and may do so in a mannersubstantially as is known in the art.

With reference now to FIG. 3, the cartridge 106 has an elongated body134 having a distal end 136 and a proximal end 138. The cartridge 106may be configured to removably house a plurality of staples (notillustrated in FIG. 3). A first slot 140 may be provided and shaped toreceive a cutting mechanism (e.g. cutting mechanism 108 in FIG. 2)and/or to connect or receive a clamping or translating mechanism. Withbrief reference to FIGS. 1B and 21, a clamping mechanism may include afirst member 118 or an upper flange 506 configured to apply a movingfulcrum force to the anvil 102 as the clamping mechanism 502 travelsdistally. In some embodiments, the clamping mechanism 502 is a cuttingmechanism 108 or comprises a cutting portion 206. A second slot 142shaped to house at least a first one of the plurality of staples, and athird slot 144 shaped to house at least a second one of the plurality ofstaples may also be provided.

As illustrated in FIG. 4, the second and third slots 142, 144 may beshaped, configured, or positioned so as to house the first staple at anangle Θ oblique to the second slot or staple. In some embodiments, theangle Θ between the second slot 142 and the third slot 144 is betweenabout 4 degrees and about 30 degrees. In some embodiments, the angle Θis between about 10 degrees and about 20 degrees. In some embodiments,the angle Θ is between about 10 degrees and about 15 degrees. In someembodiments, the angle Θ is between about 15 degrees and about 20degrees. In some embodiments, the angle Θ is about 15 degrees plus orminus a suitable manufacturing tolerance. In some embodiments, the angleΘ is between about 12 degrees and about 18 degrees.

As illustrated in FIG. 5, in some embodiments, the second slot 142 isshaped to translatably house at least a first staple pusher 146, and thethird slot 144 is shaped to translatably house at least a second staplepusher 148. The second slot 142 and the third slot 144 may be configuredto limit the first staple pusher 146 to translation at an angle Θoblique to a translation of the second staple pusher 148.

As is also apparent in FIG. 5, in some embodiments, the first staplepusher 146 may be configured to support a first staple 150 and a thirdstaple 154, while the second staple pusher 148 may be configured tosupport a second staple 152 and a fourth staple 156. The first and thirdstaples 150, 154 may be held substantially parallel to each other, whilethe second and fourth staples 152, 156 may be held substantiallyparallel to each other. The first and second staple pushers 146, 148 maybe housed at an oblique angle Θ relative to each other, and thecartridge 106 may be configured to limit translation of the staplepushers 146, 148 along relative paths that are oblique to each other.

The housing 104 or support jaw 103 may have an envelope diameter D of5.6 mm or 5.5 mm, and may house or carry staples having a nominal leglength of 3.0 mm. In some embodiments, the housing 104 or support jaw103 may house or carry a plurality of staples 150, 152, 154, 156 havinga nominal leg length of 3.5 mm, as is illustrated in FIG. 5. The staples150, 152, 154, 156 may be housed such that a first staple 150 and asecond staple 152 are carried on opposing sides of a longitudinal axisdefined by the housing 104, cartridge 106, or support jaw 103, or, asillustrated in FIG. 5, by a slot 140 for a cutting mechanism 108. Thefirst and second staples 150, 152 may be angled relative to each othersuch that the legs of the first staple 150 and the legs of the secondstaple 152 form an angle Θ with each other. The angle Θ may be an acuteangle Θ in some embodiments. In some embodiments, the angle Θ may bebetween about 4 degrees and about 30 degrees. In some embodiments, thestaples 150, 152 may be mirrored on either side of the longitudinal axisor slot 140 such that the first staple 150 is rotated between about 2degrees and about 15 degrees from a vertical orientation or from theslot 140, and the second staple 152 may be rotated in an opposingdirection between about 2 degrees and about 15 degrees from the verticalorientation or slot 140. In some embodiments, the angle Θ between thefirst staple 150 and the second staple 152 may be up to about 90degrees. A third staple 154 may be parallel to the first staple 150, anda fourth staple 156 may be parallel to the second staple 152. The thirdand fourth staples 154, 156 may be closer to the longitudinal axis thanare the first and second staples 150, 152.

It should be understood that the surgical stapler 100 may carry or housemore than four staples. The first and second staples (and third andfourth staples if applicable) 150, 152, 154, 156 may be near a distal orworking end of the surgical stapler 100, while another set of staplesmay be more proximal to the user. The staples 150, 152, 154, 156 mayinclude a plurality of B-form staples in a staggered formation, so as toprovide a suitable closing of tissue. That is, the staples may be in aformation wherein a distal leg of a proximal staple is positioned moredistal than is a proximal leg of a distal staple, such that a portion ofthe proximal and distal staples are next to each other and a portion isnot. Any suitable number of sets of staples may be provided.

With simultaneous reference now to FIGS. 5-7, in some embodiments, oneor more of the staples 150, 152, 154, 156 are partially cupped orsupported by a corner or features 166, 168, 170 in the second or thirdslots 142, 144. That is, cupped regions 158, 160, 162, 164 in the staplepusher(s) 146, 148 may partially support the staples 150, 152, 154, 156.In some embodiments, a cupped region 158 in a first staple pusher 146may work in unison with a wall 170 and cupped regions 166, 168 in theelongated body 134 of the cartridge 106 to substantially limit a firststaple 150 to translation as the first staple 150 is pushed by way of acam (e.g. cam 128 in FIG. 2) and the first staple pusher (e.g. firststaple pusher 146 in FIG. 5). Put another way, in some embodiments, awall 170 and cupped regions 166, 168 in the cartridge 106 may provideprimary support or guidance of the staple(s) 150, 152, 154, 156.

It should be understood that when referencing limiting a staple 150,152, 154, 156 to translation, some lateral or rotational give or motionis generally acceptable. Although only two staple pushers 146, 148 aredescribed herein, those skilled in the art will understand that anynumber of staple pushers 146, 148 may be provided, generally along twopaths such as two slots 142, 144 that are on opposing sides of a slot140 along which tissue is to be cut, so as to ensure tissue is stapledtogether on either side of the cut. The staple pushers 146, 148, slots142, 144, and cartridge 106 may be configured to place the staples 150,152, 154, 156 in two rows of staggered staples 150, 152, 154, 156 toensure the stapled portion of the tissue is properly clamped and stapledshut across the entire transection length.

With continued reference generally to FIGS. 3-7, the cartridge 106and/or stapler 100 may be configured to house or place staples 150, 152,154, 156 in a patient, wherein at least one of the staples 150, 152,154, 156 has a leg length of 3.42 mm or greater, or a nominal leg lengthof 3.5 mm or greater, and the anvil 102 and the support jaw 103 areconfigured to pass through a cannula 400 having an inner diameter of 5.6mm or less or a nominal inner diameter of 5 mm or less. In someembodiments, at least one of the staples 150, 152, 154, 156 has anominal leg length of 4.8 mm or greater or a leg length of 4.72 mm orgreater, and the anvil 102 and the support jaw 103 are configured topass through a cannula 400 having a nominal inner diameter of 8 mm orless or an inner diameter of 8.6 mm or less.

In some embodiments, the stapler 100 is configured to pass through acannula 400 having an inner diameter 402, and the stapler 100 issimultaneously configured to carry at least first and second staples150, 152 for placement in a patient, at least one of the staples 150,152 having a leg length L that is at least 53% of the inner diameter 402of the cannula 400, or at least 53% of an envelope diameter D of thestapler 100 when the stapler is in a closed configuration (see e.g. FIG.1B).

In some embodiments, the leg length L is at least 58% of the innerdiameter 402 or the envelope diameter D. In some embodiments, the leglength L is at least 60% of the inner diameter 402 of the cannula 400 orthe envelope diameter D. In some embodiments, the leg length L is atleast 61% of the inner diameter 402 of the cannula 400 or the envelopediameter D. For example, a staple 150 having a nominal leg length of 4.8mm and a cannula 400 having a nominal inner diameter of 8.0 may have aratio of 4.72/8.6 after taking into account manufacturing allowances.For example, a staple 150 having a nominal leg length of 4.8 mm and acannula 400 having a nominal inner diameter of 8.0 may have a ratio of4.88/8.0 at a less-than ideal tolerance stack-up.

In some embodiments, the leg length L is up to 62% of the inner diameterof the cannula 400 or the envelope diameter D. In some embodiments, theleg length L is up to 66% of the inner diameter 402 of the cannula 400or the envelope diameter D. For example, a staple 150 having a nominalleg length of 3.5 mm and a cannula 400 having a nominal diameter of 5 mmmay have a ratio of 3.58/5.0 at a less-than ideal tolerance stack-up. Insome embodiments, the leg length L is between 55% and 67% of the innerdiameter 402.

In some embodiments, the stapler 100 is configured to (a) pass through acannula 400 having an inner diameter 402, (b) place at least first andsecond staples 150, 152 in a patient, each of the staples 150, 152having a first leg length L1 that is between 55% and 67% of the innerdiameter 402 of the cannula 400, and (c) place at least third and fourthstaples 154, 156 in a patient, the third and fourth staples 154, 156having a second leg length L2 that is different from the first leglength L1 of the first and second staples 150, 152. In some embodiments,the first leg length L1 is at least 57% of the inner diameter 402. Insome embodiments, the first leg length is at least 58% of the innerdiameter 402. In some embodiments, the first leg length is at least 61%of the inner diameter 402.

In some embodiments, the stapler 100 is configured to place a firststaple 150 having a first leg length L1 and another staple 156 having adifferent leg length L2. In some embodiments, the stapler 100 isconfigured to place staples having a first leg length L1 on a first sideof a tissue cut, and staples having a second leg length L2 on a secondside of a tissue cut. In some embodiments, the stapler 100 is configuredto place a first staple having a first leg length L1 and a second staplehaving a second leg length L2 on the same side of the tissue cut.

In some embodiments, the stapler 100 is configured with an outerenvelope diameter D (see e.g. FIG. 1B) sized to pass through a cannulahaving an inner diameter 402 when the stapler 100 is in a closedconfiguration (see e.g. FIG. 15) wherein the curved interfaces 202, 204abut one another. The stapler 100 may be configured to clamp tissuepositioned between the anvil 102 and the support jaw 103 and compressthe tissue to a particular thickness and/or to limit the tissue to amaximum particular thickness, herein referred to as a device gap G,between the anvil 102 and the cartridge 106 (see e.g. FIG. 14). Thoseskilled in the art will understand that surgical staplers 100 and theassociated staples are generally sized according to the intendedthickness of tissue to be stapled.

For the purpose of this document, the device gap G is defined as themaximum space allowed between the support jaw 103 or cartridge 106 andthe anvil 102 at the time the device fires staple(s) 150 into tissue.

In one example, the stapler 100, if positioned about very thin tissue,may be configured to or allowed to “float” towards contact between theanvil 102 and support jaw 103 and then, as staple(s) 150 are fired intothe tissue, the stapler 100 may be configured to allow the staple(s) 150to bias or push the anvil 102 away from the cartridge 106, up to amaximum device gap G. The maximum device gap G may be limited to adistance defined by a translating cutting mechanism 108 (see e.g. FIGS.14, 20C). The cutting mechanism 108 may move distally substantially ornearly simultaneously or in coordination with one or more cam(s) 128,130, such as when the staple(s) 150 are fired, so as to prevent thestapler 100 from opening beyond the maximum device gap G.

Relatedly, and as another example, the stapler 100, if positioned aboutrelatively thick tissue, may be configured to compress the tissue downto the maximum device gap G as the translating cutting mechanism 108moves distally. For example, if the stapler 100 is configured to clamptissue at a device gap G of 2.0 mm, and the tissue positioned betweenthe stapler 100 is greater than 2.0 mm, the stapler 100 and/or cuttingmechanism 108 may compress the tissue appropriately. Of note, if thetissue positioned between the anvil 102 and the support jaw 103 is sothick as to not be compressible to the appropriate device gap G, thecutting mechanism 108 may be configured to jam or stop translating intotissue that is not suitably clamped.

For example, most currently-available 5 mm (nominal) staplers areindicated for stapling tissue that can be clamped to less than 1.0 mm,while the Cardica 5 mm stapler (nominal—the actual size is greater than5 mm, about 5.8 mm or more) is indicated for stapling tissue that caneasily be clamped to 1.5 mm or less, and uses D-form staples. In bothcases, if the surgeon wishes to staple tissue having a greaterthickness, a larger stapler must be used. Relatedly, currently-availableB-form staples having a nominal leg length of 3.5 mm are indicated forstapling tissue that can be clamped to between 1.5 mm and 2.0 mm.Currently-available B-form staples having a nominal leg length of 4.8 mmare indicated for stapling tissue that can be clamped to 2.0 mm.

In some embodiments, the envelope diameter D is about 5.5 mm or about5.6 mm, and the device gap G is between about 0.75 mm and about 1.0 mm.In some embodiments, the envelope diameter D is about 5.5 mm or 5.6 mm,and the device gap G is between about 1.0 mm and about 1.5 mm. In someembodiments, the envelope diameter D is about 5.5 mm or 5.6 mm, and thedevice gap G is greater than about 1.5 mm, and up to about 2.0 mm. Insome embodiments, the envelope diameter D is about 8.5 mm or 8.6 mm, andthe device gap G is about 2.0 mm or greater.

In some embodiments, the device gap G is 13% of the envelope diameter Dor greater. In some embodiments, the device gap G is 17% of the envelopediameter D or greater. In some embodiments, the device gap G is 20% ofthe envelope diameter D or greater. In some embodiments, the device gapG is 22% of the envelope diameter D or greater. In some embodiments, thedevice gap G is 26.8% of the envelope diameter D or greater. In someembodiments, the device gap G is 27.3% of the envelope diameter D orgreater. In some embodiments, the device gap G is about 37% of theenvelope diameter D or less. In some embodiments, the device gap G isbetween about 18% and about 37% of the envelope diameter D. In someembodiments, the device gap G is between about 22% and about 37% of theenvelope diameter D. In some embodiments, the device gap G is betweenabout 26.8% and about 35.7% of the envelope diameter D. In someembodiments, the device gap G is between 27.3% and about 36.4% of theenvelope diameter D.

In some embodiments, the stapler 100 is modular, as illustrated in FIG.2 or FIG. 6. That is, one or more interchangeable cartridge kits 105 maybe provided. For example, a first cartridge kit 105 having a cartridge106, one or more staple pushers 132, and one or more staples (notillustrated) having a first leg length may be interchangeable with asecond cartridge kit 105 having a cartridge 106, one or more staplepushers 132, and one or more staples (not illustrated) having a secondleg length that is different from the first leg length. In someembodiments, the cartridge kit(s) 105 is removable from a housing 104 orsupport jaw 103. In some embodiments, alignment features are provided inthe housing 104, support jaw 103, and/or cartridge 106 to enablesuitable alignment. In some embodiments, the cartridge kit 105 isremovable from the support jaw 103 without the use of tools. In someembodiments, locking features may be provided in the cartridge kit 105so as to prevent removal without the use of a tool. In some embodiments,the cartridge kit 105, housing 104, anvil 102, cutting mechanism 108,upper and/or lower anvil positioners 110, 112, and shaft 116 areremovable as a unit from the stapler actuator 800.

Turning now to FIGS. 8-11, and as illustrated in FIG. 1, the stapler 100may have an anvil 102. The anvil 102 may be shaped or configured to bemovable relative to the support jaw 103, for example, by way of alinkage mechanism 172. The linkage mechanism 172 may include one or morerecesses or passages 174 in one of the anvil 102 or the support jaw 103(or the housing 104 in the support jaw 103), configured to engage withone or more corresponding protrusions 176 (see FIG. 2) in the other oneof the anvil 102 or the support jaw 103 (or the housing 104 in thesupport jaw 103). The linkage mechanism 172 may be configured to limitthe anvil 102 to rotation and translation relative to the support jaw103 or housing 104. The linkage mechanism 172 may be configured toadjust a pivot point of the anvil 102 as the anvil 102 is rotatedrelative to the support jaw 103 or housing 104. The linkage mechanism172 may include one or more recesses or passages 174 in the support jaw103 and one or more protrusions 176 in the anvil 102.

The linkage mechanism 172 may work in a coordinated manner with theupper and/or lower anvil positioners 110, 112 so as to effectuate,enable, and/or limit motion of the anvil 102 to movement between an openposition, a clamped position, and a closed position (see e.g. FIGS.15-17). Those skilled in the art will understand that, although thelinkage mechanism 172 is illustrated as having a passage 174 in theanvil 102 and a protrusion 176 in the support jaw 103 or housing 104,any number of linkage mechanisms 172 may be employed.

In some embodiments, the linkage mechanism 172 includes a snap-fitbetween an elastic region of the anvil 102 and the support jaw 103 orhousing 104. For example, the anvil 102 may have a slight protrusion onone or both sides that correspond to pits, passages, or recesses in thesupport jaw 103 or housing 104. During assembly, the anvil 102 may becaused to flex slightly, so as to snap-fit to the support jaw 103 orhousing 104. In some embodiments, the elastic region may be created by athin wall section in the anvil 102.

In some embodiments, one or more detents (not illustrated) may beprovided in the anvil 102 and/or support jaw 103, and the detents may beconfigured to engage one or more recesses or passages in the other ofthe anvil 102 and/or support jaw 103, so as to enable assembly a tightfit between the anvil 102 and support jaw 103. A detent/recess/passagemay be configured to allow a user, recycler, and/or manufacturer todisassemble the anvil 102 from the support jaw 103.

Continuing with FIG. 8, in some embodiments, the anvil 102 or linkagemechanism 172 may include a tissue stop mechanism 178. The tissue stopmechanism 178 may be a feature in the anvil 102 and/or the support jaw103 (or cartridge 106 or housing 104) configured to prevent tissue frombeing positioned beyond the stapling region between the anvil 102 andthe support jaw 103. That is, the tissue stop mechanism 178 isconfigured to prevent the stapler 100 from cutting tissue that is notstapled. In some embodiments, the tissue stop mechanism 178 includes asurface 180 in the anvil 102 that is selected and shaped so as to notengage a surface 182 in the cartridge 106 (see e.g. FIGS. 14-15) anddamage tissue clamped between the support jaw 103 and the anvil 102 whenthe anvil is moved from the open position to the clamped position.

The anvil 102 may also have a slot 184 shaped and configured to receiveor guide a cutting mechanism 108 or a member 118, 120 of a cuttingmechanism 108 as the cutting mechanism 108 travels distally to cuttissue clamped between the support jaw 103 and the anvil 102. The slot184 may extend from the proximal region 186 of the anvil 102 to aposition short of the distal end 188 of the anvil 102. The slot 184 maybe shaped to limit the cutting mechanism 108 or member 118, 120 thereofto translation and/or prevent the cutting mechanism 108 or member 118,120 from extending beyond the distal end 188 of the anvil 102.

In some embodiments, the anvil 102 has one or more guides 190 (see e.g.FIG. 9), configured to guide the cutting mechanism 108 or member 118,120 of the cutting mechanism 108 as the cutting mechanism 108 travelsdown the anvil 102 (see e.g. FIGS. 20A-20C). The guides 190 in the anvil102 may correspond to or engage guides 192 in the cutting mechanism 108.In some embodiments, the guide(s) 190 in the anvil 102 may be one ormore recesses 190 that engage corresponding one or more ridges orprotrusions 192 in the upper member 118 of the cutting mechanism 108, asillustrated.

In some embodiments, guides 192 in the cutting mechanism 108 may beprotrusions that do not extend an entire length of the cutting mechanism108 or member 118, 120, so as to reduce friction between the cuttingmechanism 108 or member 118, 120 and the anvil 102.

In some embodiments, the guide(s) 192 in the cutting mechanism 108 maybe recesses (not illustrated). In some embodiments, the guide(s) 190 inthe anvil 102 may be protrusions (not illustrated) in the anvil 102. Insome embodiments the anvil 102 may have a first guide 190 that is arecess or groove, and a second guide 190 that is a protrusion or flange(not illustrated). Those skilled in the art will readily envision anynumber of means of providing a first and/or second guide 190 to guidethe cutting mechanism 108 as it travels towards the distal region of thestapler 100, all of which means are contemplated herein.

In some embodiments, the anvil 102 is sized so as to fit through acannula 400 having a nominal inner diameter of 8.0 mm. In someembodiments, the anvil 102 is sized so as to fit through a cannula 400having an inner diameter of 8.6 mm or less. In some embodiments, theanvil 102 is sized so as to fit through a cannula 400 having a nominalinner diameter of 5.5 mm. In some embodiments, the anvil 102 is sized soas to fit through a cannula 400 having an inner diameter of 5.6 mm orless.

Continuing with FIGS. 9-13, the anvil 102 may have first and/or secondcam guides 194, 196. The cam guide(s) 194, 196 may be slots in a portionof the anvil 102 configured to guide one or more cams 128, 130 (see FIG.2) as the cam(s) 128, 130 move or translate longitudinally into thesupport jaw 103 or housing 104 to cause motion of the staple pusher(s)132 and/or the staple(s) 132, 146, 148. The cam guide(s) 194, 196 mayassist in maintaining the cam(s) 128, 130 positioned at an angle Θrelative to each other; for example, the second and/or third slots 142,144 in the cartridge 106 and the cam guide(s) 194, 196 may guide thetranslating cam(s) 128, 130 at an oblique angle Θ relative to eachother, so as to effectuate motion of the staple pushers 132, 146, 148 atthe oblique angle Θ relative to each other (see also FIG. 5 illustratedthe cartridge 106). Put another way, the cam guides 1974, 196 mayeffectuate a first travel path on a first staple pusher 146 and a secondtravel path on a second staple pusher 148, the first travel path beingat an oblique angle Θ relative to the second travel path.

With brief reference to FIGS. 11 and 13, the anvil 102 may have a curvedtissue clamping interface 202, and the cartridge 106 may have a curvedtissue clamping interface 204 (see e.g. FIG. 3) configured to oppose thecurved tissue clamping interface 202 of the anvil 102 when the stapler100 is in a clamped or closed configuration (see e.g. FIGS. 15 and 17).That is, in some embodiments, the anvil 102 may be curved to provide acurved beam in flexure and utilize the compression strength of thematerial to react against the staple forming forces from the opposingsides. More specifically, the curved beam may prevent the anvil 102 fromundesired deformation; in turn, the curved beam may assist in properstaple formation. Those skilled in the art will understand that the term“curved tissue clamping interface” is intended to reference a generallycurved clamping surface that may or may not be interrupted by one ormore recesses, protrusions, and/or flat regions.

Together, the curved tissue clamping interfaces 202, 204 may beconfigured to clamp tissue therebetween when the anvil 102 is in theclamped position (illustrated in FIG. 17). The curved tissue clampinginterfaces 202, 204 may be configured to abut or nest together when theanvil 102 is in the closed position (illustrated in FIG. 15). In someembodiments, a portion of one or both of the curved tissue clampinginterfaces 202, 204 may have a radius of curvature R that is between 40%and 60% of the envelope diameter. For example, for an envelope diameterof 5.6 mm, the radius of curvature R may be between 2.24 mm and 3.36 mm.In some embodiments, the envelope diameter D may be about 5.6 mm, andthe radius of curvature R may be between about 2.6 mm and about 2.8 mm.In some embodiments, the radius of curvature may be about 48% of theenvelope diameter D, or about 2.69 mm where the envelope diameter D is5.6 mm.

A portion of the curved tissue clamping interface 204 in the cartridge106 may have a corresponding or similarly constrained radius ofcurvature, so as to nest with or clamp tissue with the anvil 102. Insome embodiments, a portion of one or both of the curved tissue clampinginterfaces 202, 204 has a radius of curvature between 45% and 55% of theenvelope diameter. In some embodiments, the radius of curvature isbetween 47% and 52% of the envelope diameter.

The curved tissue clamping interfaces 202,204 may be configured toprovide a cuff that is larger than a cuff normally achieved withstaplers having similar nominal sizes (e.g. envelope diameters). Thoseskilled in the art will understand that a cuff in stapled and transectedtissue is defined as the distance from the edge of the transected tissueto the first inside staple row. Cuff width is important because agreater cuff reduces the likelihood that the tissue will pull throughthe staples, or that the staples will tear out. In some embodiments, thecuff width W is greater than 0.5 mm. In some embodiments, the cuff widthW is greater than 0.6 mm. In some embodiments, the cuff width W is about0.7 mm, or greater. In some embodiments, the cuff width W is 0.8 mm orgreater. In some embodiments, the cuff width W is 0.9 mm or greater. Insome embodiments, the cuff width W is about 1.6 mm. In some embodiments,the cuff width W is greater than 0.5 mm up to about 1.6 mm. In someembodiments, the envelope diameter D is 5.6 mm or less, and the cuffwidth W is greater than 0.5 mm. In some embodiments, the envelopediameter D is 5.6 mm or less, and the cuff width W is about 0.7 mm. Insome embodiments, the cuff width W is a function of the angle Θ, aradius of curvature of the curved tissue clamping interfaces 202, 204,and the size of the staples 150. The staples 150 and angle Θ may beconfigured based on currently known standard leg sizes, or as yet to bedeveloped standard sizes, such as, for example, 2.0 mm, 2.5 mm, 3.0 mm,3.5 mm, 3.8 mm, 4.1 mm, 4.8 mm, or others.

Returning now to FIG. 12, the anvil 102 may have one or more formingpockets 198 configured to form and/or fold the staples(s) 150, 152, 154,156 as the staple(s) 150, 152, 154, 156 are pushed out of the cartridge106 and through tissue, into the anvil 102. The forming pocket(s) 198may be configured substantially in a manner as is known in the art.However, the forming pockets 198 may be angled or positioned in a mannersuitable for properly forming the staple(s) 150, 152, 154, 156 inembodiments in which the staple(s) 150, 52, 154, 156 and staple pushers132, 146, 148 translate at an angle Θ relative to each other, orembodiments in which the anvil 102 and cartridge 106 have curved tissueclamping interfaces 202, 204. The forming pockets 198 may interruptengagement of tissue by the curved tissue clamping interface 202.

Turning now to FIG. 14, in some embodiments, the stapler 100 may providefor a substantially consistent fixed maximum device gap G across atransverse cross-section of tissue and/or a longitudinal cross-sectionof tissue during staple firing and/or tissue clamping. In someembodiments, the forming pockets 184 in the anvil 102 are shaped andpositioned so as to assist in guiding or driving staples 150, 152, 154,156 in a direction normal to tissue clamped between the anvil 102 andcartridge 106 or support jaw 103. In some embodiments, the stapler 100has an envelope diameter D of 5.6 mm or less in a closed configuration,and is configured to allow a maximum device gap G of greater than 1.5mm, and up to 2.0 mm between the curved tissue clamping interfaces 202,204. In some embodiments, the stapler 100 has an envelope diameter of8.6 mm or less in a closed configuration, and is configured to allow amaximum device gap G of 2.0 mm or more.

In some embodiments, the stapler 100 is configured fit through a cannula400 having an inner diameter 402 of 5.6 mm or less in a closedconfiguration, and to place staples having a nominal leg length L of 3.5mm in a patient while allowing a maximum device gap G of more than 1.5mm between the curved tissue clamping interfaces 202, 204. In someembodiments, the stapler 100 is configured to fit through a cannula 400having an inner diameter 402 of 8.6 mm or less in a closedconfiguration, and to place staples having a nominal leg length L of 4.8mm in a patient and allow a maximum device gap G of at least 2.0 mmbetween the curved tissue clamping interfaces 202, 204.

In some embodiments, an angle Θ between a first set of staples 150, 154and a second set of staples 152, 156, provides a relatively wide cuff,as previously described herein. The wider cuff achieved using a stapler100 configured for a 5.5 mm cannula 400 may be comparable to a cuffachieved using a standard stapler configured for a 12 mm diametercannula 400, and may be about 0.7 mm or more. In some embodiments, acurved cartridge 106 and rotated or angled staple(s) create additionalspace between the knife/cutting mechanism and the inner row of staples,increasing the width of the tissue “cuff” that is created followingstaple formation and tissue transection.

Continuing with FIG. 14, lead-in features 185 of the forming pockets 184may match the rotation angle Θ of the staples within the cartridge 106.See also FIG. 10. That is, the lead-in features 185 may be between about4 degrees and about 30 degrees from each other, or less than or up toabout 90 degrees from each other in some embodiments. The lead-infeatures 185 may include any lead-in means, including bevels, chamfers,reliefs, or any other features known in the art and configured to assistin guiding staples into the forming pockets 184.

Turning now to FIGS. 15-17, as previously described, the anvil 102 maybe movable relative to the support jaw 103 between a closed position asillustrated in FIG. 15, an open position as illustrated in FIG. 16, anda clamped position as illustrated in FIG. 17. In the closed position,the anvil 102 and support jaw 103 may have a compressed envelopedimension or diameter D. That is, the anvil 102 and support jaw 103together may be configured to pass through a passage having an innerdimension of a particular nominal size. For example, the closed envelopedimension may have a closed envelope diameter D configured to passthrough a cannula 400 having an inner dimension or diameter 402 of aparticular nominal size, such as 8.6 mm or 5.6 mm in some embodiments.

In some embodiments, the stapler 100 may be tip-biased. That is, theanvil 102 and/or support jaw 103 may be shaped such that a distal end ofthe stapler 100 will tend to contact first when the stapler 100 is movedtowards a closed configuration. A tip-biased stapler 100 may beconfigured such that a slight flexure of the anvil 102 and/or supportjaw 103 allows full compression to a closed configuration wherein theanvil 102 and cartridge 106 make contact along a substantial or majorityportion of the clamping interfaces 202, 204.

After passing through or partially through the cannula 400, the anvil102 may be actuated to move into an open position, such as the openposition illustrated in FIG. 16. In the open position, the anvil 102 maybe rotated, rotated and translated, or moved such that a distal portion188 of the anvil 102 is positioned further away from the support jaw 103than is the proximal portion 186. With the stapler 100 in the openconfiguration, a surgeon may place tissue between the support jaw 103and the anvil 102 in preparation for surgical cutting and/or stapling oftissue.

As illustrated in FIG. 17, the anvil 102 may be movable to a clampedposition. The clamped position may be selected or designed so as toachieve a substantially consistent maximum device gap G (see e.g. FIGS.10, 14) between the anvil 102 and the cartridge 106 or support jaw 103,or between the clamping interfaces 202, 204 thereof, during firing andas previously described herein. In some embodiments, the clampedposition may be selected or designed such that the anvil 102 and supportjaw 103 have an envelope dimension or diameter D2 that is greater in theclamped configuration than the compressed envelope dimension or diameterD in the closed configuration. In some embodiments, the clampedconfiguration results in an envelope dimension or diameter D that isgreater than the inner diameter 402 or dimension of the cannula 400through which the stapler 100 has been passed.

In some embodiments, an upper anvil positioner 110 and a lower anvilpositioner 112 may be provided and configured to effectuate motion ofthe anvil 102 relative to the support jaw 103. That is, the upper anvilpositioner 110 and/or the lower anvil positioner 112 may be configuredto manipulate or move a pivot point of the anvil 102 as the anvil 102 ismoved between the closed, open, and/or clamped positions.

Turning now to FIGS. 18-20C, and as previously described, the stapler100 may have an expandable cutting mechanism 108 and/or clamping memberconfigured to move between a collapsed configuration and an expandedconfiguration. FIG. 18 illustrates the cutting mechanism 108 in acollapsed configuration, and FIG. 19 illustrates the cutting mechanismin an expanded configuration.

In the collapsed configuration (e.g. FIG. 18), the cutting mechanism 108may have a height H or envelope diameter that is less than a combinedheight of the anvil 102 and the support jaw 103 (or the rest of thestapler 100 generally) or less than the envelope diameter D. In theexpanded configuration (e.g. FIG. 19), the cutting mechanism 108 mayhave or may approach a height H that is greater than a combined heightof the anvil 102 and the support jaw 103 when the anvil 102 is in theclamped configuration. Put another way, the height H of the cuttingmechanism 108 in the collapsed configuration may be less than theenvelope diameter D of the stapler 100 when the stapler 100 is in theclosed and/or clamped configurations. In some embodiments, the height Hof the cutting mechanism 108 in the collapsed configuration may be lessthan the combined envelope diameter of the anvil 102 and the support jaw103 when the stapler 100 or anvil 102 is in the closed and/or clampedconfigurations or positions. In some embodiments, the height H of thecutting mechanism 108 in the expanded configuration may be greater thanthe combined envelope diameter D of the anvil 102 and the support jaw103 when the stapler 100 or anvil 102 is in the closed and/or clampedconfiguration or position. The height H of the cutting mechanism 108 inthe collapsed configuration may be less than the inner diameter 402 ofthe cannula 400. The height H of the cutting mechanism 108 in theexpanded configuration may be greater than the inner diameter 402 of thecannula 400.

The expandable cutting mechanism 108 may have a first member 118 and asecond member 120 that are expandable, translatable, or movable relativeto each other. In some embodiments, a first one of the members 118, 120is movable both longitudinally and transversely relative to the supportjaw 103 or cartridge 106, and a second one of the members 118, 120 islimited to longitudinal movement relative to the support jaw 103 orcartridge 106. In some embodiments, both of the members 118, 120 aremovable both longitudinally and transversely relative to the support jaw103 or cartridge 106. In some embodiments, a first one of the members118, 120 is rotatable relative to a second one of the members 118, 120.That is, for example, a first member 118, 120 may rotate slightly as thecutting member 108 expands to move up the anvil 102 and support jaw 103.The slight rotation may be limited by flanges and/or legs in the members118, 120.

One of the members 118, 120 may have a knife edge or cutting portion206, and may be configured to travel through or partially through a slot140 in the cartridge 106 and/or a slot 184 in the anvil 102 so as to cuttissue clamped between the anvil 102 and the support jaw 103. The otherone of the members 118, 120 may be configured to travel with the firstmember 118, 120, such that, together, the first and second members 118,120 may provide a strengthening effect on the stapler 100. Morespecifically, and as illustrated in FIG. 20C, the cutting mechanism 108may be configured to apply a supportive clamping force on tissue clampedbetween the anvil 102 and the support jaw 103 when the cutting mechanism108 is in a distal position and/or moving distally, and expanded aboutthe anvil 102 and support jaw 103.

In some embodiments, the upper anvil positioner 110 is configured torotate relative to the support jaw 103 and assist in guiding the cuttingmechanism 108.

In some embodiments, the expandable cutting mechanism 108 is coupled toor comprises a first actuator 122 coupled to one of the members 118,120, such as the first member 118, and a second actuator coupled to theother one of the members 118, 129, such as the second member 120. Insome embodiments one or both of the actuators 122, 124 is flexible. Insome embodiments, a first actuator 122 is configured to apply aretracting force when actuated (e.g. pull the cutting mechanism 108towards the user or proximal region of the stapler 100), and a secondactuator 124 is configured to apply an extending force when actuated(e.g. push the cutting mechanism 108 away from the user or towards thedistal region of the stapler 100). In some embodiments, a flexibleactuator 122, 124 may be configured with a suitable rigidity formaintaining the member 118, 120 to which the actuator 122, 124 iscoupled oriented relative to the other member 118, 120. Put another way,an actuator 122, 124, such as the first actuator 122 may provide alimited pushing or extending force on the cutting mechanism 108, and agreater retracting force when retraction is required.

In some embodiments, the cutting mechanism 108 is configured to movebetween a collapsed configuration wherein the cutting portion 206 is notin line with a tissue cutting region defined by the anvil 102 and thesupport jaw 103 and an expanded configuration wherein the cuttingportion 206 is in line with the tissue cutting region, the tissuecutting region defined by a device gap G between the anvil 102 and thesupport jaw 103 (see e.g. FIGS. 19 and 20A-20C).

One or both of the actuators 122, 124, (as illustrated, the firstactuator 122) may be configured so as to be flexible enough to allow theexpandable cutting mechanism 108 to expand (e.g. the first member 118may move upward and/or the second member 120 may move downward) as theexpandable cutting mechanism 108 travels distally, and rigid enough toapply a strong enough force to cause the member 118, 120 to which theactuator 122, 124 is attached to move distally, or at least remainoriented relative to the other member. That is, in some embodiments thefirst actuator 122 may orient the first member 118 relative to thesecond member 120 while the second actuator 124 primarily causes thecutting mechanism 108 to move distally.

It should be understood that the first and second actuators 122, 124 maybe coupled to the first and second members 118, 120 using any meansknown in the art and suitable for ensuring reliable control of the firstand second members 118, 120. In some embodiments, one or bothactuator(s) 122, 124 has a number of layers that are fused together, ormay comprise a laminated beam. For example, a plurality of layers 122 a,122 b, 122 c, 122 d comprising a high strength steel may be provided,and coupled to each other using a binding agent to achieve a suitableflexibility in the actuator 122, 124 and extending force on the member118, 120. In some embodiments, neither actuator 122, 124 has a laminatedbeam, but may comprise a material selected for a suitable flexibilityand strength for positioning the cutting mechanism 108 or member 118,120. That is, the actuator(s) 122, 124 should be selected so as to bestrong enough to push the cutting mechanism 108 or member(s) 118, 120distally and flexible enough to move with the cutting mechanism 108 ormember(s) 118, 120 as the cutting mechanism 108 expands outside theenvelope diameter D.

Continuing with FIGS. 18-19, those skilled in the art will understandthat the cutting mechanism 108 may be made of any suitable materialsknown in the art and suitable for cutting tissue clamped between theanvil 102 and the support jaw 103 or cartridge 106. For example, thefirst member 118 may be formed of a surgical steel and polished ormachined so as to have a sharp cutting portion 206. In some embodiments,the first member 118 has one or more legs 208 with a flange portion(s)210 that are configured to engage one or more flanges 214 in one or morelegs 212 in the second member 120, so as to limit the amount ofexpansion possible between the first and second members 118, 120. Insome embodiments, the legs 208, 212 are configured to allow one member118, 120 to rotate a given amount relative to the other member 118, 120.In some embodiments, the cartridge 106, slot 140, and/or anvil 102 areconfigured to maintain a vertical orientation of the cutting mechanism108.

The cutting mechanism 108 may have a means for limiting expansionbetween the first and second members 118, 120 to a pre-determinedexpanded height H, for example, such that, at maximum expansion, thecutting mechanism 108 is configured to assist in preventing the anvil102 from deforming while clamping tissue. In some embodiments, thecutting mechanism 108 is configured to limit a tissue clamping gapbetween the anvil 102 and support jaw 103 to a device gap G that issuitable for clamping, cutting, and/or stapling tissue. For example, insome embodiments, the cutting mechanism 108 is configured to squeeze theanvil 102 towards the support jaw 103 a given amount as the cuttingmechanism 108 travels from a proximal position towards a distalposition. As illustrated most clearly in FIG. 19, in some embodiments, aleading portion 119 of the first member 118 and/or a leading portion 121of the second member 120 may be positioned on the cutting mechanism 108at a region that is more distal to the user than is the cutting surface206. The leading portion(s) 119, 121 may be configured to apply acompressive force on the anvil 102 and support jaw 103 so as to ensurethe device gap G is reached prior to a tissue cut, and/or to ensure themaximum device gap G is not exceeded during a tissue cut.

In some embodiments, the cutting mechanism 108 is configured to jam ornot travel into a region where the maximum device gap G is not achieved.For example, if the stapler 100 is configured to achieve a maximumdevice gap G of 2.0 mm, but a portion of the tissue cannot be compressedto 2.0 mm, the cutting mechanism 108 will not travel into regions oftissue that are too thick. In this event, even if the stapler 100 hasinadvertently fired staples into the tissue, and those staples are notproperly formed, the cutting mechanism 108 will not cut that portion ofthe tissue that is not properly stapled. The surgeon may then manuallyretract the cutting mechanism 108, and pry the improperly formed staplesout of the tissue.

As illustrated in FIG. 19, those skilled in the art will understand thatany part of the first member 118 or the second member 120 may be madeunitary, or any part may be a separate component coupled to othercomponents of the cutting mechanism 108. In some embodiments, the legs208, 212 of the members 118, 120 may be independent features coupled tocurved guide portions 118 a, 120 a of the members 118, 120.

With reference now to FIG. 21, in some embodiments, the surgical stapler500 may have an anchored clamp mechanism 502 with a cutting surface 206as previously described herein. The anchored clamp mechanism 502 mayinclude a modified I-beam having a first or lower flange 504 and asecond or upper flange 506 coupled together such that the modifiedI-beam does not extend all the way through the diameter of the endeffectors, as is the case in currently-available designs. Instead, theI-beam may be anchored at the first flange 504 within the cartridge 508,for example, in the space created by the angle of the staples. In someembodiments, the I-beam may include a first flange 504 shaped toslidingly engage a flange or recess in the cartridge 508. The I-beam mayinclude a surface on one or more of the flanges 504, 506 shaped toslidingly engage an outer surface of the clamp or end effector of thesurgical stapler 500.

In some embodiments, the anchored clamp mechanism 502, cutting mechanism108, or I-beam may be shaped to slide to trail the cam(s) 128, 130 andact as a moving fulcrum in a manner substantially as previouslydescribed with reference to the cutting mechanism 108. In someembodiments, the anchored clamp mechanism 502, cutting mechanism 108, orI-beam may be shaped to slide or travel distally

As illustrated in FIG. 21, the first flange 504 may allow the anchoredclamp mechanism to slide through a recess or channel cutout in thecartridge, while allowing or limiting the maximum device gap G in amanner substantially as previously described with reference to thecutting mechanism 108.

Turning now to FIGS. 22-24, a staple pusher 148 is illustrated infurther detail. The staple pusher 148 may comprise a first cupped region160 and a second cupped region 164 configured to support two staplessubstantially as previously described herein. In some embodiments, thecupped regions 160, 164 are configured to support the staples in astaggered but parallel orientation, so as to ensure that the stapledtissue is sealed. As illustrated in FIG. 22, the staple pusher(s) 148may have a first cammed surface 216 and/or a second cammed surface 218that is/are configured to, in coordination with a translating cam 128,130 and the cartridge 106, convert longitudinal motion of thetranslating cam 128, 130 into a transverse motion, such as at an angle Θoblique relative to another staple pusher 132 to drive staples intotissue clamped between the anvil 102 and the support jaw 103.

FIG. 25 illustrates the lower anvil positioner 112 having, as previouslydescribed, flanges 112 a, 112 b for assisting in positioning the anvil102, although those skilled in the art will understand that a singleflange 112 a, 112 b may be suitable or implemented. In some embodiments,the flanges 112 a 112 b are coupled together by way of a bridge 112 c toenable a single actuator (not illustrated) to effectuate a motion of thelower anvil positioner 112 and/or flange(s) 112 a, 112 b. In someembodiments, the lower anvil positioner 112 has a bridge 112 d forcoupling the flanges 112 a, 112 b.

FIG. 26 illustrates a relationship between the cutting mechanism 108,the spring 113, and the upper anvil positioner 110.

As illustrated in FIGS. 27-28, in some embodiments, a cartridge housingis not provided. That is, a cartridge 106 and cartridge housing 104 maybe integrated in to one piece, an integrated staple housing 107, to forman outer casing. The integrated staple housing 107 may have features toproperly guide the staple(s) out of the housing 107 as they are drivenby the cam 128, 130 (and staple pusher(s) 132). In embodiments having anintegrated staple housing 107, an insert 109, may be coupled to, placedin, or snapped into the center of the integrated housing 107 to completethe medial features of the staple pocket 111. Additionally, the staplepusher(s) 132 may be modified (trimmed) or suitably sized so as to makespace to increase a housing wall thickness for strength.

In some embodiments, an integrated staple housing providing staplesguided by the housing walls as illustrated in FIGS. 5 and/or 29-30 mayallow for an increase in wall thickness of the cartridge 508 or housing,and thereby an increased strength of the surgical stapler as compared tostaplers in which the pushers may cup the staples. Contrast FIGS. 29-30with FIGS. 31-32.

In some embodiments, the stapler herein disclosed may be used in aflexible catheter. In some embodiments, the stapler 100 disclosed hereinis configured to couple to or to be used with an articulating joint.

As illustrated in FIGS. 20A-20C and/or 33-34, an anchor clamp mechanism502 or cutting mechanism 108 may provide a safety lock feature. In someembodiments, the mechanism 502, 108 may travel such that that, if toomuch tissue is clamped (thereby not achieving the necessary gappreviously described herein), the mechanism 502, 108 is unable to traveldown the anvil 102, and will self-jam, preventing the firing procedurefrom continuing.

Turning now to FIG. 36, in some embodiments, a method 3600 of performinga stapling procedure on a patient is provided. The method 3600 mayinclude providing 3602 a surgical stapler in a closed position,inserting 3604 at least a portion of the stapler through a cannula, andmoving 3606 the stapler from the closed position to a clamped position.

Providing 3602 a surgical stapler in a closed configuration may includeproviding a surgical stapler having any of the features previouslydescribed herein with reference to FIGS. 1-35B. In some embodiments,providing 3602 includes providing a stapler comprising: an anvil movablycoupled to a support jaw; wherein the support jaw comprises a cartridgehaving an elongated body having a distal end and a proximal end andconfigured to removably house a plurality of staples. The elongated bodymay have a first slot shaped to receive a cutting mechanism, a secondslot shaped to house at least a first one of the plurality of staples,and a third slot shaped to house at least a second one of the pluralityof staples at an angle oblique to the first one of the plurality ofstaples.

Causing 3604 at least a portion of the surgical stapler to pass througha cannula may include causing at least a portion of the stapler to passthrough a cannula having an inner diameter. The cannula may besubstantially as previously described herein with reference to FIGS.1-35B.

Causing 3606 the surgical stapler to move from the closed configurationto the clamped configuration may include causing the stapler to move toa clamped configuration wherein the surgical stapler maintains a gapbetween the anvil and the support jaw, and the surgical stapler isunable to pass through the cannula. Causing 3606 the stapler to move tothe clamped configuration may be achieved using a stapler as previouslydescribed with reference to FIGS. 1-35B.

The method 3600 may include stapling tissue using a staple having a leglength of 3.0 mm or more using a stapler configured to pass through acannula 400 that has an inner diameter of 5.6 mm or less. The method3600 may include using a stapler that has an envelope diameter of 5.6 mmor less when in a closed position to staple tissue clamped to athickness that is greater than 1.5 mm.

In some embodiments, the method 3600 further includes longitudinallytranslating at least one cam to cause at least one of a first staplepusher or a second staple pusher in a direction oblique to the other oneof the first staple pusher or the second staple pusher.

In some embodiments, the method 3600 further includes replacing a firstcartridge kit in the surgical stapler with a second cartridge kit. Themethod 3600 may further include using the stapler having the firstcartridge kit to place first set of a plurality of staples having afirst leg length in a patient, replacing the cartridge kit, and usingthe stapler having the second cartridge kit to place a second set of aplurality of staples having a second leg length different from the firstleg length in a patient. In some embodiments, the same patient receivesboth sets of staples.

In addition to the description above, various specific examples aredisclosed herein.

Example 1: A cartridge for a surgical stapler, comprising: an elongatedbody configured to fit within an envelope diameter and to removablyhouse a plurality of B-form staples, at least one of the plurality ofB-form staples having a base length and a leg length, the leg length atleast 53% of the envelope diameter; a first slot shaped to receive atranslating cutting mechanism; a second slot shaped to house at least afirst one of the plurality of staples; and a third slot shaped to houseat least a second one of the plurality of staples at an angle oblique tothe first one of the plurality of staples.

Example 2: The cartridge of example 1, further comprising: a curvedtissue clamping interface; and wherein the oblique angle is betweenabout 4 degrees and about 30 degrees.

Example 3: The cartridge of example 1 or example 2, wherein: the secondslot is shaped to translatably house at least a first staple pusher; thethird slot is shaped to translatably house at least a second staplepusher; and the second slot and the third slot are configured to limitthe first staple pusher to translation at an angle oblique totranslation of the second staple pusher.

Example 4: The cartridge of example 1, wherein: the second slot isshaped to translatably house at least a first staple pusher shaped tosupport at least the first one of the plurality of staples and a thirdone of the plurality of staples parallel to the first one of theplurality of staples; the third slot is shaped to translatably house atleast a second staple pusher oblique to the first staple pusher, thesecond staple pusher shaped to support at least the second one of theplurality of staples and a fourth one of the plurality of staplesparallel to the second one of the plurality of staples.

Example 5: The cartridge of example any one of the preceding examples,wherein one of: at least one of the plurality of staples has a leglength of 3.42 mm or greater, and the envelope diameter is 5.6 mm orless; or at least one of the plurality of staples has a nominal leglength of 4.72 mm or greater, and the envelope diameter is 8.6 mm orless.

Example 6: The cartridge of example 3 or example 4, wherein: the secondslot is shaped to slidably receive a first longitudinally translatingcam to effectuate a sliding motion of the first staple pusher; and thethird slot is shaped to slidably receive a second longitudinallytranslating cam to effectuate a sliding motion of the second staplepusher oblique to the sliding motion of the first staple pusher.

Example 7: The cartridge of any one of the preceding examples, whereinthe cartridge comprises a curved tissue clamping interface; and thecartridge is configured to position at least one of the plurality ofstaples at an angle normal to the curved tissue clamping interface.

Example 8: The cartridge of example 7, wherein: the curved tissueclamping interface is curved about a longitudinal axis extending betweena proximal end and a distal end of the elongated body; and the curvedtissue clamping interface has a radius of between 40% and 60% of theenvelope diameter.

Example 9: The cartridge of example 8, wherein: the envelope diameter is5.6 mm or less; and at least one of at least the first one of theplurality of staples has a leg length of 3.42 mm or greater; or at leastthe first one of the plurality of staples is configured to form abouttissue clamped to a thickness greater than 1.5 mm.

Example 10: The cartridge of example 1, wherein one of: at least thefirst one of the plurality of staples has a leg length of 3.42 mm orgreater, and the envelope diameter is 5.6 mm or less; or at least thefirst one of the plurality of staples has a leg length of 4.72 mm orgreater, and the envelope diameter is 8.6 mm or less.

Example 11: The cartridge of any one of the preceding examples, wherein:

at least the first one of the plurality of staples is configured tostaple about tissue clamped up to a tissue thickness; and the tissuethickness is at least 20% of the envelope diameter.

Example 12: The cartridge of example 11, wherein: the tissue thicknessis between about 22% and about 36% of the envelope diameter.

Example 13: The cartridge of example 1, further comprising: a recess forcoupling to a cartridge support jaw; and wherein one of the cartridgeand the support jaw are shaped to fit within an envelope diameter of 5.6mm or less; or the cartridge and the support jaw are shaped to fitwithin an envelope diameter of 8.6 mm or less.

Example 14: The cartridge of example 1, further comprising: a curvedtissue clamping interface.

Example 15: The cartridge of any one of the preceding examples, wherein:at least one of the plurality of staples has a leg length that is atleast 61% of the envelope diameter.

Example 16: A surgical stapler, comprising: an anvil movably coupled toa support jaw between a clamped configuration wherein the anvil and thesupport jaw are configured to clamp tissue positioned therebetween, anda closed configuration wherein a tissue clamping interface in the anvilabuts a tissue clamping interface in the cartridge; wherein the supportjaw comprises a cartridge having an elongated body configured toremovably house a plurality of B-form staples, at least one of theplurality of B-form staples having a base length and a leg length, thecartridge further comprising a first slot shaped to receive atranslating cutting mechanism, a second slot shaped to house at least afirst one of the plurality of staples, and a third slot shaped to houseat least a second one of the plurality of staples at an angle oblique tothe first one of the plurality of staples; the anvil and the support jawcomprising the cartridge are shaped to fit within an envelope diameterwhen in the closed configuration; and the leg length of the at least oneof the plurality of B-form staples is at least 53% of the envelopediameter.

Example 17: The stapler of example 16, wherein: the third slot is shapedto house the second one of the plurality of staples at an angle ofbetween about 4 degrees and about 30 degrees relative to the first oneof the plurality of staples.

Example 18: The stapler of example 16 or example 17, wherein: the secondslot is shaped to translatably house at least a first staple pusher; thethird slot is shaped to translatably house at least a second staplepusher; and the second slot and the third slot are configured to limitthe first staple pusher to translation at an angle oblique totranslation of the second staple pusher.

Example 19: The stapler of example 16, wherein: the second slot isshaped to translatably house at least a first staple pusher shaped tosupport at least the first one of the plurality of staples and a thirdone of the plurality of staples parallel to the first one of theplurality of staples; the third slot is shaped to translatably house atleast a second staple pusher oblique to the first staple pusher, thesecond staple pusher shaped to support at least the second one of theplurality of staples and a fourth one of the plurality of staples.

Example 20: The stapler of any one of examples 16-19, wherein one of: atleast one of the plurality of staples has a leg length of 3.42 mm orgreater, and the envelope diameter is 5.6 mm or less; or at least one ofthe plurality of staples has a leg length of 4.72 mm or greater, and theenvelope diameter is 8.6 mm or less; or the envelope diameter is 5.6 mmor less, and the stapler is configured to staple and cut tissueresulting in a cuff width of greater than 0.5 mm.

Example 21: The stapler of example 19, further comprising: a firstlongitudinally translating cam; a second longitudinally translating campositioned oblique to the first longitudinally translating cam; andwherein the second slot is shaped to slidably receive the firstlongitudinally translating cam to effectuate a sliding motion of thefirst staple pusher; and the third slot is shaped to slidably receivethe second longitudinally translating cam to effectuate a sliding motionof the second staple pusher oblique to the sliding motion of the firststaple pusher.

Example 22: The stapler of any one of examples 16-21, furthercomprising: an expandable cutting mechanism configured to move between acollapsed configuration wherein the cutting mechanism is shaped to fitwithin the envelope diameter and an expanded configuration wherein thecutting mechanism has a dimension that is greater than the envelopediameter.

Example 23: The stapler of examples 16-21, further comprising: anexpandable cutting mechanism having a first member with a cuttingportion and a second member; wherein the cutting mechanism is configuredto move between a collapsed configuration wherein the cutting portiondoes not intersect a longitudinal axis defined by the tissue clampinginterface of the cartridge and an expanded configuration wherein thecutting portion intersects the longitudinal axis defined by the tissueclamping interface of the cartridge.

Example 24: The stapler of any one of examples 16-23, wherein one of: atleast the first one of the plurality of staples has a leg length of 3.42mm or greater, and the envelope diameter is 5.6 mm or less; or at leastthe first one of the plurality of staples has a leg length of 4.72 mm orgreater, and the envelope diameter is 8.6 mm or less.

Example 25: The surgical stapler of example 16 or example 24, wherein:the surgical stapler is configured to staple and cut tissue up to apre-defined tissue thickness; the tissue thickness is defined as adistance between the anvil and the cartridge during stapling; and thetissue thickness is at least 20% of the envelope diameter when thestapler is in the closed configuration.

Example 26: The stapler of any one of examples 16-25, wherein: the anvilhas a curved tissue clamping interface; and the cartridge has a curvedtissue clamping interface shaped to engage the curved tissue clampinginterface of the anvil when the stapler is in the closed configuration.

Example 27: The stapler of any one of examples 16-26, wherein: at leastone of the plurality of staples has a leg length that is at least 61% ofthe envelope diameter.

Example 28: A method of placing a surgical staple in a patient,comprising: providing a surgical stapler in a closed configuration, thestapler comprising an anvil movably coupled to a support jaw between aclamped configuration wherein the anvil and the support jaw areconfigured to clamp tissue positioned therebetween, and a closedconfiguration wherein a tissue clamping interface in the anvil abuts atissue clamping interface in the cartridge, wherein the support jawcomprises a cartridge configured to removably house a plurality ofB-form staples, at least one of the plurality of B-form staples having abase length and a leg length, the cartridge further comprising a firstslot shaped to receive a translating cutting mechanism, a second slotshaped to house at least a first one of the plurality of staples, and athird slot shaped to house at least a second one of the plurality ofstaples at an angle oblique to the first one of the plurality ofstaples, the anvil and the support jaw comprising the cartridge areshaped to fit within an envelope diameter when in the closedconfiguration, and the leg length of the at least one of the pluralityof B-form staples is at least 53% of the envelope diameter; passing atleast a portion of the stapler in the closed configuration through anenvelope diameter; positioning tissue between the anvil and the supportjaw; moving the anvil to the clamped configuration wherein the anvil andthe support jaw clamp the tissue; and causing the stapler to form theplurality of staples about the tissue.

Example 29: The method of example 28, further comprising: housing athird one of the plurality of staples parallel to the first one of theplurality of staples; and housing a fourth one of the plurality ofstaples parallel to the second one of the plurality of staples; andwherein one of the surgical stapler has an envelope diameter of 5.6 mmor less; or the surgical stapler has an envelope diameter of 8.6 mm orless.

Example 30: The method of example 28, further comprising: clampingtissue between a curved tissue clamping interface in the support jaw anda curved tissue clamping interface in the anvil.

Example 31: A surgical stapler, comprising: an anvil movably coupled toa support jaw between a clamped configuration wherein the anvil and thesupport jaw are configured to clamp tissue positioned therebetween, anda closed configuration wherein a tissue clamping interface in the anvilabuts a tissue clamping interface in the cartridge, the anvil and thesupport jaw defining an envelope diameter when the anvil is in theclosed configuration; and a translating cutting mechanism having a firstmember having a cutting portion, and a second member, the cuttingmechanism movable between a collapsed configuration wherein the cuttingmechanism is shaped to fit within the envelope diameter and an expandedconfiguration wherein the cutting mechanism does not fit within theenvelope diameter; wherein the support jaw comprises a cartridge havinga first slot shaped to receive the translating cutting mechanism, asecond slot shaped to house at least a first one of the plurality ofstaples, and a third slot shaped to house at least a second one of theplurality of staples.

Example 32: The surgical stapler of example 31, wherein: at least one ofthe first member or the second member has at least one guide, the atleast one guide configured to engage a corresponding guide on the anvilto limit the cutting mechanism to translation relative to thecorresponding guide.

Example 33: The surgical stapler of example 31 or example 32, whereinone of: the envelope diameter is 5.6 mm or less; or the envelopediameter is 8.6 mm or less.

Example 34: The surgical stapler any one of examples 31-33, furthercomprising: a first actuator coupled to the first member, the firstmember configured to move the first member distally and onto the anvil;and a second actuator coupled to the second member, the actuatorconfigured to move the second member distally and onto the support jaw.

Example 35: The surgical stapler of example 34, wherein: the firstactuator comprises a flexible member.

Example 36: The surgical stapler of any one of examples 31-35, wherein:the first member comprises at least one leg having a first flange; andthe second member comprises at least one leg having a second flange, thefirst flange and the second flange shaped to limit expansion of thecutting mechanism.

Example 37: The surgical stapler of any one of examples 31-36, wherein:the cutting mechanism is configured to compress the anvil and thesupport jaw towards each other and into the clamped configuration as thecutting mechanism translates towards a distal end of the surgicalstapler.

Example 38: The surgical stapler of any one of examples 31-37, wherein:the stapler has an envelope diameter of 5.6 mm in the closedconfiguration, and is configured to staple and cut tissue clampedbetween the anvil and the support jaw such that the cut tissue has acuff width of greater than 0.5 mm.

Each of the various elements disclosed herein may be achieved in avariety of manners. This disclosure should be understood to encompasseach such variation, be it a variation of an embodiment of any apparatusembodiment, a method or process embodiment, or even merely a variationof any element of these. Particularly, it should be understood that thewords for each element may be expressed by equivalent apparatus terms ormethod terms—even if only the function or result is the same. Suchequivalent, broader, or even more generic terms should be considered tobe encompassed in the description of each element or action. Such termscan be substituted where desired to make explicit the implicitly broadcoverage to which this invention is entitled.

As but one example, it should be understood that all action may beexpressed as a means for taking that action or as an element whichcauses that action. Similarly, each physical element disclosed should beunderstood to encompass a disclosure of the action which that physicalelement facilitates. Regarding this last aspect, by way of example only,the disclosure of a clamp should be understood to encompass disclosureof the act of clamping—whether explicitly discussed or not—and,conversely, were there only disclosure of the act of clamping, such adisclosure should be understood to encompass disclosure of a “clampingmechanism”. Such changes and alternative terms are to be understood tobe explicitly included in the description.

The previous description of the disclosed embodiments is provided toenable any person skilled in the art to make or use the presentinvention. Various modifications to these embodiments will be readilyapparent to those skilled in the art, and the generic principles definedherein may be applied to other embodiments without departing from thespirit or scope of the invention. Thus, the present invention is notintended to be limited to the embodiments shown herein but is to beaccorded the widest scope consistent with the principles and novelfeatures disclosed herein.

What is claimed is:
 1. A cartridge for a surgical stapler, comprising:an elongated body configured to fit within an envelope diameter and toremovably house a plurality of B-form staples, at least one of theplurality of B-form staples having a base length and a leg length, theleg length at least 53% of the envelope diameter; a first slot shaped toreceive a translating cutting mechanism; a second slot shaped to houseat least a first one of the plurality of staples; and a third slotshaped to house at least a second one of the plurality of staples at anangle oblique to the first one of the plurality of staples.
 2. Thecartridge of claim 1, further comprising: a curved tissue clampinginterface; and wherein the oblique angle is between about 4 degrees andabout 30 degrees.
 3. The cartridge of claim 1, wherein: the second slotis shaped to translatably house at least a first staple pusher; thethird slot is shaped to translatably house at least a second staplepusher; and the second slot and the third slot are configured to limitthe first staple pusher to translation at an angle oblique totranslation of the second staple pusher.
 4. The cartridge of claim 1,wherein: the second slot is shaped to translatably house at least afirst staple pusher shaped to support at least the first one of theplurality of staples and a third one of the plurality of staplesparallel to the first one of the plurality of staples; the third slot isshaped to translatably house at least a second staple pusher oblique tothe first staple pusher, the second staple pusher shaped to support atleast the second one of the plurality of staples and a fourth one of theplurality of staples parallel to the second one of the plurality ofstaples.
 5. The cartridge of claim 4, wherein one of: at least one ofthe plurality of staples has a leg length of 3.42 mm or greater, and theenvelope diameter is 5.6 mm or less; or at least one of the plurality ofstaples has a nominal leg length of 4.72 mm or greater, and the envelopediameter is 8.6 mm or less.
 6. The cartridge of claim 4, wherein: thesecond slot is shaped to slidably receive a first longitudinallytranslating cam to effectuate a sliding motion of the first staplepusher; and the third slot is shaped to slidably receive a secondlongitudinally translating cam to effectuate a sliding motion of thesecond staple pusher oblique to the sliding motion of the first staplepusher.
 7. The cartridge of claim 1, wherein: the cartridge comprises acurved tissue clamping interface; and the cartridge is configured toposition at least one of the plurality of staples at an angle normal tothe curved tissue clamping interface.
 8. The cartridge of claim 7,wherein: the curved tissue clamping interface is curved about alongitudinal axis extending between a proximal end and a distal end ofthe elongated body; and the curved tissue clamping interface has aradius of between 40% and 60% of the envelope diameter.
 9. The cartridgeof claim 8, wherein: the envelope diameter is 5.6 mm or less; and atleast one of (a) at least the first one of the plurality of staples hasa leg length of 3.42 mm or greater; or (b) at least the first one of theplurality of staples is configured to form about tissue clamped to athickness greater than 1.5 mm.
 10. The cartridge of claim 1, wherein oneof: at least the first one of the plurality of staples has a leg lengthof 3.42 mm or greater, and the envelope diameter is 5.6 mm or less; orat least the first one of the plurality of staples has a leg length of4.72 mm or greater, and the envelope diameter is 8.6 mm or less.
 11. Thecartridge of claim 1, wherein: at least the first one of the pluralityof staples is configured to staple about tissue clamped up to a tissuethickness; and the tissue thickness is at least 20% of the envelopediameter.
 12. The cartridge of claim 11, wherein: the tissue thicknessis between about 22% and about 36% of the envelope diameter.
 13. Thecartridge of claim 1, further comprising: a recess for coupling to acartridge support jaw; and wherein one of the cartridge and the supportjaw are shaped to fit within an envelope diameter of 5.6 mm or less; orthe cartridge and the support jaw are shaped to fit within an envelopediameter of 8.6 mm or less.
 14. The cartridge of claim 1, furthercomprising: a curved tissue clamping interface.
 15. The cartridge ofclaim 1, wherein: at least one of the plurality of staples has a leglength that is at least 61% of the envelope diameter.
 16. A surgicalstapler, comprising: an anvil movably coupled to a support jaw between aclamped configuration wherein the anvil and the support jaw areconfigured to clamp tissue positioned therebetween, and a closedconfiguration wherein a tissue clamping interface in the anvil abuts atissue clamping interface in the cartridge; wherein the support jawcomprises a cartridge having an elongated body configured to removablyhouse a plurality of B-form staples, at least one of the plurality ofB-form staples having a base length and a leg length, the cartridgefurther comprising a first slot shaped to receive a translating cuttingmechanism, a second slot shaped to house at least a first one of theplurality of staples, and a third slot shaped to house at least a secondone of the plurality of staples at an angle oblique to the first one ofthe plurality of staples; the anvil and the support jaw comprising thecartridge are shaped to fit within an envelope diameter when in theclosed configuration; and the leg length of the at least one of theplurality of B-form staples is at least 53% of the envelope diameter.17. The stapler of claim 16, wherein: the third slot is shaped to housethe second one of the plurality of staples at an angle of between about4 degrees and about 30 degrees relative to the first one of theplurality of staples.
 18. The stapler of claim 16, wherein: the secondslot is shaped to translatably house at least a first staple pusher; thethird slot is shaped to translatably house at least a second staplepusher; and the second slot and the third slot are configured to limitthe first staple pusher to translation at an angle oblique totranslation of the second staple pusher.
 19. The stapler of claim 16,wherein: the second slot is shaped to translatably house at least afirst staple pusher shaped to support at least the first one of theplurality of staples and a third one of the plurality of staplesparallel to the first one of the plurality of staples; the third slot isshaped to translatably house at least a second staple pusher oblique tothe first staple pusher, the second staple pusher shaped to support atleast the second one of the plurality of staples and a fourth one of theplurality of staples.
 20. The stapler of claim 19, wherein one of: atleast one of the plurality of staples has a leg length of 3.42 mm orgreater, and the envelope diameter is 5.6 mm or less; or at least one ofthe plurality of staples has a leg length of 4.72 mm or greater, and theenvelope diameter is 8.6 mm or less; or the envelope diameter is 5.6 mmor less, and the stapler is configured to staple and cut tissueresulting in a cuff width of greater than 0.5 mm.
 21. The stapler ofclaim 19, further comprising: a first longitudinally translating cam; asecond longitudinally translating cam positioned oblique to the firstlongitudinally translating cam; and wherein the second slot is shaped toslidably receive the first longitudinally translating cam to effectuatea sliding motion of the first staple pusher; and the third slot isshaped to slidably receive the second longitudinally translating cam toeffectuate a sliding motion of the second staple pusher oblique to thesliding motion of the first staple pusher.
 22. The stapler of claim 16,further comprising: an expandable cutting mechanism configured to movebetween a collapsed configuration wherein the cutting mechanism isshaped to fit within the envelope diameter and an expanded configurationwherein the cutting mechanism has a dimension that is greater than theenvelope diameter.
 23. The stapler of claim 16, further comprising: anexpandable cutting mechanism having a first member with a cuttingportion and a second member; wherein the cutting mechanism is configuredto move between a collapsed configuration wherein the cutting portiondoes not intersect a longitudinal axis defined by the tissue clampinginterface of the cartridge and an expanded configuration wherein thecutting portion intersects the longitudinal axis defined by the tissueclamping interface of the cartridge.
 24. The stapler of claim 16,wherein one of: at least the first one of the plurality of staples has aleg length of 3.42 mm or greater, and the envelope diameter is 5.6 mm orless; or at least the first one of the plurality of staples has a leglength of 4.72 mm or greater, and the envelope diameter is 8.6 mm orless.
 25. The surgical stapler of claim 16, wherein: the surgicalstapler is configured to staple and cut tissue up to a pre-definedtissue thickness; the tissue thickness is defined as a distance betweenthe anvil and the cartridge during stapling; and the tissue thickness isat least 20% of the envelope diameter when the stapler is in the closedconfiguration.
 26. The stapler of claim 16, wherein: the anvil has acurved tissue clamping interface; and the cartridge has a curved tissueclamping interface shaped to engage the curved tissue clamping interfaceof the anvil when the stapler is in the closed configuration.
 27. Thestapler of claim 16, wherein: at least one of the plurality of stapleshas a leg length that is at least 61% of the envelope diameter.
 28. Amethod of placing a surgical staple in a patient, comprising: providinga surgical stapler in a closed configuration, the stapler comprising ananvil movably coupled to a support jaw between a clamped configurationwherein the anvil and the support jaw are configured to clamp tissuepositioned therebetween, and a closed configuration wherein a tissueclamping interface in the anvil abuts a tissue clamping interface in thecartridge, wherein the support jaw comprises a cartridge configured toremovably house a plurality of B-form staples, at least one of theplurality of B-form staples having a base length and a leg length, thecartridge further comprising a first slot shaped to receive atranslating cutting mechanism, a second slot shaped to house at least afirst one of the plurality of staples, and a third slot shaped to houseat least a second one of the plurality of staples at an angle oblique tothe first one of the plurality of staples, the anvil and the support jawcomprising the cartridge are shaped to fit within an envelope diameterwhen in the closed configuration, and the leg length of the at least oneof the plurality of B-form staples is at least 53% of the envelopediameter; passing at least a portion of the stapler in the closedconfiguration through an envelope diameter; positioning tissue betweenthe anvil and the support jaw; moving the anvil to the clampedconfiguration wherein the anvil and the support jaw clamp the tissue;and causing the stapler to form the plurality of staples about thetissue.
 29. The method of claim 28, further comprising: housing a thirdone of the plurality of staples parallel to the first one of theplurality of staples; and housing a fourth one of the plurality ofstaples parallel to the second one of the plurality of staples; andwherein one of the surgical stapler has an envelope diameter of 5.6 mmor less; or the surgical stapler has an envelope diameter of 8.6 mm orless.
 30. The method of claim 28, further comprising: clamping tissuebetween a curved tissue clamping interface in the support jaw and acurved tissue clamping interface in the anvil.